What the label lists and what reports show
Aripiprazole lauroxil side effects
Aripiprazole lauroxil's FDA label: “The most common adverse reaction (incidence ≥5% and at least twice the rate of placebo in patients treated with ARISTADA) was akathisia.” FAERS holds 4,532 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is needle issue (637 reports).
- No generic listed
- Boxed warning
Check it at the source: the aripiprazole lauroxil FDA label on DailyMed (effective January 28, 2025, Alkermes, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ARISTADA?ARISTADA may cause serious side effects, including: See “ What is the most important information I should know about ARISTADA? ” Cerebrovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death. Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs symptoms of NMS: high fever stiff muscles confusion sweating changes in pulse, heart rate, and blood pressure Uncontrolled body movements (tardive dyskinesia). ARISTADA may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving ARISTADA. Tardive dyskinesia may also start after you stop receiving ARISTADA. […]
Source: FDA drug label, Alkermes, Inc., effective January 28, 2025 (SPL set 17a8d11b-73b0-4833-a0b4-cf1ef85edefb), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reaction (incidence ≥5% and at least twice the rate of placebo in patients treated with ARISTADA) was akathisia.
Table 8: Adverse Reaction in 2% or More of ARISTADA-Treated Patients and That Occurred at Greater Incidence than in the Placebo-Treated Patients in the 12-Week, Placebo-Controlled, Fixed-Dose Schizophrenia Trial
| Reaction | Adverse Reaction System Organ Class Preferred Term | Placebo N=207 (%) | Aripiprazole Lauroxil |
|---|---|---|---|
| Injection site pain | 2 | 3 | 4 |
| Increased weight | 1 | 2 | 2 |
| Increased blood creatine phosphokinase | 0 | 2 | 1 |
| Akathisia | 4 | 11 | 11 |
| Headache | 3 | 3 | 5 |
| Insomnia | 2 | 3 | 4 |
| Restlessness | 1 | 3 | 1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following are discussed in more details in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-related Psychosis [see Boxed Warning, Warnings and Precautions ( 5.1 )] Cerebrovascular Adverse Reactions, Including Stroke [see Boxed Warning, Warnings and Precautions ( 5.2 )] Neuroleptic Malignant Syndrome [see Warnings and Precautions ( 5.4 )] Tardive Dyskinesia [see Warnings and Precautions ( 5.5 )] Metabolic Changes [see Warnings and Precautions ( 5.6 )] Pathological Gambling and Other Compulsive Behaviors [see Warnings and Precautions ( 5.7 )] Orthostatic Hypotension [see Warnings and Precautions ( 5.8 )] Falls [see Warnings and Precautions ( 5.9 )] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions ( 5.10 )] Seizures [see Warnings and Precautions ( 5.11 )] Potential for Cognitive and Motor Impairment [see Warnings and Precautions ( 5.12 )] Body Temperature Regulation [see Warnings and Precautions ( 5.13 )] Dysphagia [see Warnings and Precautions ( 5.14 )] Most commonly observed adverse reaction with ARISTADA (incidence ≥5% and at least twice that for placebo) was akathisia ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Alkermes, Inc. at 1-866-274-7823 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Alkermes, Inc., effective January 28, 2025 (SPL set 17a8d11b-73b0-4833-a0b4-cf1ef85edefb), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,532 reports list aripiprazole lauroxil among the medicines taken, each a report of something that happened, not proof the medicine caused it; 81 are coded as a death and 523 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 17 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Aripiprazole lauroxil: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions